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    Summary
    EudraCT Number:2015-005774-37
    Sponsor's Protocol Code Number:GETNE-2016-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-02-23
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2015-005774-37
    A.3Full title of the trial
    Phase II study to evaluate efficacy of rechallenge with Sunitinib in Patients with Metastatic Pancreatic Neuroendocrine Tumor (pNETs) well differentiated G1/2 advanced or metastatic who previously failed to sunitinib (The RESUNET Trial)
    Estudio fase II para evaluar la eficacia del retratamiento con sunitinib en pacientes con tumores neuroendocrinos pancreáticos bien diferenciados G1/2 (pNET) avanzados o metastásicos que ya han fracasado a un tratamiento con sunitinib previo (Estudio RESUNET)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate efficacy of rechallenge with Sunitinib in Patients with Pancreatic Neuroendocrine Tumor who previously failed to sunitinib
    Estudio evaluar la eficacia del retratamiento con sunitinib en pacientes con tumores neuroendocrinos pancreáticos que ya han fracasado a un tratamiento con sunitinib previo
    A.3.2Name or abbreviated title of the trial where available
    RESUNET
    A.4.1Sponsor's protocol code numberGETNE-2016-01
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGrupo Español de Tumores Neuroendocrinos. SECRETARÍA TÉCNICA GETNE (GETNE)
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPfizer
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAPICES
    B.5.2Functional name of contact pointClinical Research Department
    B.5.3 Address:
    B.5.3.1Street AddressAv. Antonio López, 16 - 1ºA
    B.5.3.2Town/ cityPinto (MADRID)
    B.5.3.3Post code28320
    B.5.3.4CountrySpain
    B.5.4Telephone number+34918166804103
    B.5.5Fax number+34918169172
    B.5.6E-mailjuanluis.sanz@apices.es
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSunitinib
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsUNITINIB
    D.3.9.1CAS number 341031-54-7
    D.3.9.3Other descriptive nameSUNITINIB MALATE
    D.3.9.4EV Substance CodeSUB22366
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsUNITINIB
    D.3.9.1CAS number 341031-54-7
    D.3.9.3Other descriptive nameSUNITINIB MALATE
    D.3.9.4EV Substance CodeSUB22366
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic Pancreatic Neuroendocrine Tumor (pNETs) well differentiated G1/2 advanced or metastatic
    Tumores neuroendocrinos pancreáticos bien diferenciados G1/2 (pNET) avanzados o metastásicos
    E.1.1.1Medical condition in easily understood language
    Pancreatic Neuroendocrine Tumor
    Tumores neuroendocrinos pancreáticos
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10068909
    E.1.2Term Pancreatic neuroendocrine tumour metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate sunitinib efficacy in Patients with Metastatic Pancreatic Neuroendocrine Tumor (pNETs) well differentiated G1/2 advanced or metastatic who previously failed to sunitinib
    Evaluar la eficacia del retratamiento con sunitinib en pacientes con tumores neuroendocrinos pancreáticos bien diferenciados G1/2 (pNET) avanzados o metastásicos que ya han fracasado a un tratamiento con sunitinib previo
    E.2.2Secondary objectives of the trial
    Overall survival
    Time to progression
    Progression free survival
    Response duration
    Clinical benefit (CR+PR+SD)
    Overall response rate (CR+PR)
    Safety and tolerability
    Supervivencia global.
    Supervivencia libre de progresión.
    Tiempo hasta la progresión.
    Duración de la respuesta.
    Beneficio clínico (RC+RP+EE).
    Tasa de respuestas objetivas (RC+RP)
    Seguridad y tolerabilidad de sunitinib.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subjects ? 18 years old and able to give their informed consent.
    - Patients diagnosed with Neuroendocrine Tumor of pancreatic origin and histologically confirmed, G1/2 according to the WHO classification (Ki67 <20% and/or mitotic count ?20 mitoses x 10 HPF).
    - Metastatic disease progression in the 12 months prior to baseline visit documented by CT, MRI or Octreoscan.
    - Progression to prior treatment with sunitinib administered for metastatic disease and have received at least 1 line and no more than 2 lines of subsequent systemic treatment.
    - Measurable disease according to the following criteria RECIST version 1.1
    - No disease that can be treated with surgery, radiotherapy or combined treatment with curative intent.
    - ECOG 0-2.
    - Pretreatment with somatostatin analogues, chemotherapy, anti-VEGF and mTOR inhibitors prior to participation in the study is allowed.
    - Adequately controlled blood pressure (BP) <150/90 mmHg.
    - Hematologic Function:
    - Absolute neutrophil count ?1500 / uL
    - Platelets >100,000 / uL
    - Hemoglobin >5.6 mmol / L (9 g / dL)
    - Liver function: total bilirubin ? 1.5 x ULN, unless unconjugated hyperbilirubinemia or Gilbert syndrome.
    - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ? 2.5 x ULN (? 5 times in case of liver metastases).
    - Renal function: calculated creatinine clearance according to Cockcroft-Gault ? 30 ml / min.
    - Blood coagulation: prothrombin time (PT) or International Normalized Ratio (INR) ? 1.2 x UNL.
    - Proteinuria <2+ urine dipstick. If ? 2+ proteinuria, urinary protein <1 g / 24 h.
    - Life expectancy> 3 months.
    - Patient able to swallow the study drug and comply with the monitoring requirements of the study.
    - Women of childbearing potential must present a negative pregnancy test. Women of childbearing potential must agree to use contraception.
    - Men whose partners are women of childbearing potential must use effective contraception.
    - Sujetos de edad ? 18 años capaces de otorgar su consentimiento informado.
    - Pacientes con diagnóstico de TNE de origen pancreático confirmado histológicamente y que sea G1/2 según la clasificación de la OMS (Ki67 <20% y/o recuento mitótico ?20 mitosis x 10 CGA).
    - Enfermedad metastásica en progresión los 12 meses anteriores al estudio basal documentada por TC, RM u Octreoscan.
    - Progresión a un tratamiento previo con sunitinib administrado para enfermedad metastásica y, además, haber recibido al menos 1 línea y no más de 2 líneas de tratamiento sistémico posteriores.
    - Enfermedad medible según los siguientes criterios RECIST versión 1.1
    - No presentar enfermedad que pueda ser subsidiaria de tratamiento quirúrgico, radioterápico o tratamiento combinado con intención curativa.
    - ECOG 0-2.
    - Se permite el tratamiento previo con análogos de somatostatina, quimioterapia, anti-VEGF e inhibidores de mTOR antes de la participación en el estudio.
    - Presión arterial (PA) adecuadamente controlada < 150/90 mmHg.
    - Función hematológica:
    - Recuento absoluto de neutrófilos ?1500/µL
    - Plaquetas >100 000/µL
    - Hemoglobina > 5,6 mmol/L (9 g/dL)
    - Función hepática: bilirrubina total ? 1.5 veces por debajo del límite superior de la normalidad (LSN), salvo hiperbilirubinemia no conjugada o síndrome de Gilbert.
    - Alanina aminotransferasa (ALT) o aspartato aminotransferasa (AST) ? 2,5 veces por debajo del LSN (? 5 veces en caso de presencia de metástasis hepáticas).
    - Función renal: aclaramiento de creatinina calculado según la fórmula de Cockcroft-Gault ? 30 ml/min.
    - Función de coagulación: Tiempo de protrombina (TP) o Ratio internacional normalizado (INR) ? 1.2 por encima del límite superior de la normalidad (LSN).
    - Proteinuria < 2+ en tira reactiva de orina. Si proteinuria ? 2+, proteínas en orina < 1 g/24 h.
    - Esperanza de vida > 3 meses.
    - Paciente capaz de ingerir el fármaco de estudio y de cumplir con los requisitos de seguimiento del estudio.
    - Las mujeres en edad fértil deberán presentar un test de embarazo negativo. Las mujeres en edad fértil deberán acceder a utilizar métodos anticonceptivos.
    - Los hombres cuyas parejas sean mujeres en edad fértil deberán utilizar métodos anticonceptivos eficaces.
    E.4Principal exclusion criteria
    - Tumores neuroendocrinos de origen pancreático G3 según la clasificación de la OMS (Anexo 2)
    - Sujetos que han recibido 3 ó más líneas de tratamiento sistémico entre el primer tratamiento de sunitinib y su reintroducción.
    - Cirugía mayor o trauma en las 4 semanas previas a la inclusión en el estudio.
    - Tratamiento radioterápico o embolización en las 2 semanas previas a la primera dosis de sunitinib.
    - Tratamiento quimioterápico, inmunoterápico, biológico o en investigación dentro de las 2 semanas previas ó 5 semividas del último fármaco recibido antes del inicio de la primera dosis de sunitinib.
    - Tratamiento previo con quimioterapia a altas dosis que haya requerido soporte hematopoyético de rescate.
    - Tratamiento inmunosupresor o tratamiento prolongado con corticoides administrados de forma concomitante en los 3 meses previos a la inclusión en el estudio.
    - Resolución a grado <2 (según CTCAE V4.03) de todas las toxicidades relacionadas con los tratamientos previos, salvo alopecia.
    - Tratamiento, dentro de los 7 días previos a la inclusión en el estudio de fármacos inhibidores o inductores potentes conocidos de CYP3A4 o que prolongan el intervalo QT.
    - Tratamiento radioterápico previo sobre >25% de la médula ósea.
    - Presencia de enfermedad metastásica cerebral no controlada, compresión medular, carcinomatosis meníngea o enfermedad leptomeníngea.
    - Cualquier trastorno de malabsorción gastrointestinal o cualquier otro estado que, a juicio del investigador, pueda afectar a la absorción de sunitinib o incremente el riesgo de sangrado o perforación.
    - Presencia de una herida no cicatrizada o úlcera activa.
    - Diarrea grado III/IV en el período de screening.
    - Diagnóstico de una segunda neoplasia en los últimos 5 años, excepto tumores cutáneos escamosos o basaliomas adecuadamente tratados o carcinomas in situ de cérvix.
    - Enfermedad cardio/cerebrovascular clínicamente significativa en los 6 meses previos al inicio del tratamiento, que incluye:
    - Arritmias cardíacas (NCI CTCAE versión 4.0 grado ?2), fibrilación auricular de cualquier grado que requiera tratamiento médico.
    - Intervalo QTcF > 180 mseg.
    - Hemoptisis activa en las 6 semanas previas al inicio del tratamiento del estudio.
    - Evidencia de hemorragia activa o diátesis hemorrágica.
    - Presencia de lesiones endobronquiales y/o lesiones que infiltran grandes vasos.
    - Tratamiento actual con acenocumarol a dosis terapéuticas.
    - Infección conocida del virus de la inmunodeficiencia humana (VIH).
    - Presencia de una infección activa no controlada.
    - Embarazo o lactancia.
    - Reacción alérgica previa a componentes estructuralmente similares a sunitinib o a alguno de los excipientes de los fármacos.
    - Imposibilidad para interrumpir o que el paciente no desee interrumpir cualquier medicación concomitante prohibida.
    - Cualquier enfermedad (médica o psiquiátrica) o motivo que, en opinión del investigador, interfiera con la capacidad del paciente para participar en el ensayo clínico.
    - Neuroendocrine tumors of pancreatic origin G3 according to WHO classification.
    - Patients who received 3 or more lines of systemic treatment.
    - Major surgery or trauma within 4 weeks prior to the first dose of sunitinib.
    - Radiation therapy or tumor embolization within 2 weeks prior to the first dose of sunitinib.
    - Chemotherapy, immunotherapy, biologic therapy or investigational therapy within the previous 2 weeks or 5 half-lives of the drug last received before the start of the first dose of sunitinib treatment.
    - Prior treatment with high-dose chemotherapy that required hematopoietic rescue.
    - Immunosuppressive therapy or prolonged treatment with corticosteroids concomitantly administered in the previous 3 months.
    - Resolution to grade <2 (CTCAE according V4.03) of all previous related toxicities except alopecia treatments.
    - Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 (according CTCAE V4.03) and/or that is progressing in severity, except alopecia.
    - Treatment with potent inhibitors or inducers of CYP3A4 or known to prolong the QT interval in the previous 7 days.
    - Prior radiotherapy to more than 25% of the bone marrow
    - Presence of uncontrolled metastatic brain disease, spinal cord compression, meningeal carcinomatosis or leptomeningeal disease.
    - Any gastrointestinal malabsorption disorder or any other condition that, at investigator's criteria, may affect the absorption of sunitinib or increase the risk of bleeding or perforation.
    - Presence of any non-healing wound or ulcer.
    - Grade III/IV diarrhea in the screening period.
    - Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri.
    - Clinically significant cardio/cerebrovascular disease in the 6 months prior to treatment.
    - Cardiac arrhythmias (NCI CTCAE version 4.0 grade ?2), atrial fibrillation of any grade that requires medical treatment.
    - QTcF interval> 180 msec.
    - Active hemoptysis in the past 6 weeks.
    - Evidence of active bleeding or bleeding diathesis.
    - Presence of endobronchial lesions and/or lesions that infiltrate large vessels.
    - Current treatment with acenocoumarol at therapeutic doses.
    - Known HIV infection.
    - Presence of uncontrolled active infection.
    - Pregnant or breastfeeding women.
    - Previous allergic reaction to components structurally similar to sunitinib or any of the excipients.
    - Inability to discontinue any prohibited concomitant medication.
    - Any illness (medical or psychiatric) or reason, in the investigator's opinion, that interferes with the patient's ability to participate.
    E.5 End points
    E.5.1Primary end point(s)
    6 months progression free survival
    Suoervivencia libre de progresión a los 6 meses
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 meses
    E.5.2Secondary end point(s)
    - Overall survival
    - Time to progression
    - Progression free survival
    - Response duration
    - Clinical benefit (CR+PR+SD)
    - Overall response rate (CR+PR)
    - Safety and tolerability
    - Supervivencia global.
    - Supervivencia libre de progresión.
    - Tiempo hasta la progresión.
    - Duración de la respuesta.
    - Beneficio clínico (RC+RP+EE).
    - Tasa de respuestas objetivas (RC+RP)
    - Seguridad y tolerabilidad de sunitinib.
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 months
    24 meses
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state36
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-10-23
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